Do Safety Reports and SUSARs for participants from other study sites have to be submitted to our IRB?
– Study site staff at a medical center
The U. S. Food and Drug Administration (FDA) regulations require that investigators promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others. This means that any safety reports or SUSARs that did not occur at the investigator’s location only have to be reported in instances where they require a change to the research (such as a change to the protocol or consent form), or are an unanticipated problems involving risk to human subjects or others.
It can be complicated to determine what new safety information should be considered an unanticipated problems involving risk to human subjects or others, so the FDA has published guidance on adverse event reporting to IRBs. This guidance elaborates on the investigator reporting requirements and explains what types of adverse events should be considered unanticipated problems that require reporting to the IRB. It denotes that not all adverse events require reporting to the IRB and provides a bulleted list of the types of events the FDA believes meet reporting criteria.
It is also important to point out that in many multicenter studies, the sponsor has much more detailed information available about the overall safety profile and aggregate data than an individual study site. Both IRBs and the FDA generally find it acceptable to rely on an assessment of the event from the sponsor, and for the report of that event to be prepared and submitted to the IRB by the sponsor.